Our client is seeking a skilled Computer Systems Validation Engineer with experience in software change management and cybersecurity assessments. This role offers the opportunity to join a global medical device organization.
Responsibilities
The validation and operational management of computerized systems.
The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
Maintaining the quality and compliance status of associated Procedures, and work instructions.
Presenting and communicating status, reporting metrics, identifying trends potential issues, and improvement initiatives, as applicable.
Qualifications and Experience
Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
2-3 years working knowledge of software validation in med devices industry.
Experience carrying out Cyber security assessments.
Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
Benefits
Family health insurance,
Excellent pension scheme
Life assurance
Career Development
Fantastic new facility
Growing business plus access to many more benefits.
For a confidential discussion and more information on the role, please contact Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108